Navigation Links
Sanofi Pasteur announces FDA approval of menactra meningococcal conjugate vaccine indication for infants
Date:4/25/2011

Swiftwater, PA April 22, 2011 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age. This is the first U.S. approval of a meningococcal vaccine for this age group.

"Licensure of Menactra vaccine for infants as young as 9 months of age gives the opportunity to help protect infants against this potentially deadly disease when the likelihood of exposure supports a need for early protection," said Stephen I. Pelton, MD, Professor of Pediatrics and Epidemiology, Boston University Schools of Medicine and Public Health and Chief, section of Pediatric Infectious Diseases, Boston Medical Center.

Meningococcal disease is a rare but deadly disease caused by the bacterium Neisseria meningitidis. The disease can progress quickly and take the life of a child within 24 hours. Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States for active immunization against meningococcal disease caused by the serogroups contained in the vaccine (A, C, Y and W-135). More than 36 million doses of Menactra vaccine have been distributed in the United States since its licensure in 2005.

The FDA approval of Menactra vaccine for infants was based on results of one Phase II and three Phase III modified single-blind, controlled, multicenter trials in which more than 3,300 infants from the United States received Menactra vaccine using a two-dose schedule, starting as young as 9 months of age. Results from these studies showed that 2 doses of Menactra vaccine given 3 months apart elicit a robust immune response against the serogroups included in the vaccine. The studies also showed that measles-mumps-rubellavaricella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administrated concomitantly with Menactra vaccine in children. Vaccine related reactions included swelling, tenderness at injection site, and irritability.

"The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at Sanofi Pasteur. "With this approval, it is now possible to help protect persons from 9 months through 55 years of age."


'/>"/>

Contact: Amy Ba
Amy.ba@sanofipasteur.com
570-957-0717
Cooney Waters Group, Inc.
Source:Eurekalert

Related medicine news :

1. Eggs Being Produced by Recall Farms Safe, if Pasteurized, Experts Say
2. Government of Canada announces results in fight to save women and children with malaria
3. Oxford Nanopore announces licence agreement with Harvard University for graphene DNA sequencing
4. Elsevier Health Middle East announces publication of first bilingual medical title
5. International Vaccine Institute announces launch of Dengue Vaccine Initiative
6. Washington Life Sciences Discovery Fund announces grants to commercialize promising technologies
7. MSD Wellcome Trust Hilleman Laboratories announces first project
8. AIUM announces ultrasound practice accreditation in fetal echocardiography
9. American Physical Society announces Physical Review X
10. Beth Israel Deaconess Medical Center announces new AAAS Fellows
11. NARSAD announces $12.6 million for new generation of brain and behavior research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital ... area economy by obtaining investment capital for emerging technology companies. SCP has ... have already resulted in more than a million dollars of capital investment for ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Finally, a ... after venous procedures, dermaka cream can be incorporated into the post-surgical treatment plans of ... surgical procedures. , dermaka cream is very effective for bruising and causes a ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 Capricor Therapeutics, Inc. ... biotechnology company focused on the discovery, development and ... enrollment in its ongoing randomized HOPE-Duchenne clinical trial ... of its 24-patient target. Capricor expects the trial ... of 2016, and to report top line data ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 ... Tomorrow,s Leaders Scholarship is any indication, the future is ... online at www.diabetesscholars.org by the Diabetes Scholars ... in the way of academic and community service excellence. ... program since 2012, and continues to advocate for people ...
Breaking Medicine Technology: